[Edaily Reporter YU JIN-HEE ] The U.S. joint venture of Y2 Solution(011690)has released groundbreaking data on long-term efficacy in the field of cell therapies for dry age-related macular degeneration (AMD), an area that has long drawn attention from the global pharmaceutical and biotech industry. While existing treatments have only slowed the progression of the disease, this therapy has demonstrated unparalleled results by directly replacing damaged retinal cells to restore and maintain vision for 24 months. With global big pharma companies keeping a close eye on the development, the ongoing technology export (L/O) negotiations—valued in the trillions—are expected to gain further momentum.

‘Vision Regeneration’ Maintained Even at 24-Month Follow-Up… Patients Read at Least 3 Additional Lines According to ETDRS Standards

On the 29th, Luxa Biotechnology (hereinafter “Luxa”), the U.S. joint venture of Y2 Solution, presented the results of the additional follow-up observation from the Phase 1/2a clinical trial of “RPESC-RPE-4W,” a stem cell therapy candidate for dry age-related macular degeneration, during a dedicated session at “Bio Plus Co., Ltd.-Interphex Korea (BIX) 2026” held at COEX in Seoul.

This presentation focused on the long-term 24-month follow-up results for the low-dose group (Cohort 1) and interim 9-month data for the medium-dose group (Cohort 2) out of a total of 18 participants who completed the trial under U.S. Food and Drug Administration (FDA) approval. Through this clinical trial, the company not only demonstrated safety and tolerability in both the low-dose and intermediate-dose groups but also confirmed excellent visual acuity improvement and sustained effects.

The most striking finding is the long-term sustainability of visual acuity improvement. In the low-dose group, the mean best-corrected visual acuity (BCVA) in the treated eye remained stably improved compared to the pre-treatment baseline for 24 months. Notably, in the group of severe patients—who had lower visual acuity prior to treatment—BCVA improved by an average of 16.6 letters compared to the baseline. The overall average improvement in the low-dose group was 9.3 letters, and the difference in visual acuity compared to the untreated contralateral eye averaged 15.3 letters.

The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart used in the clinical trial is a standard chart with five letters arranged in a row. An average improvement of 16.6 letters means that patients were able to identify at least three additional lines on the chart. This indicates that patients who were legally blind—and unable to perform daily activities—have recovered to a level where they can lead independent lives.

Furthermore, the 9-month evaluation of the intermediate-dose group fully met all primary endpoints related to safety and tolerability. Significant biological signals suggesting stabilization of best-corrected visual acuity were also observed.

The credibility of these clinical results is further enhanced by the academic authority of the chief scientist who led the development. Dr. Sally Temple, co-founder and Chief Scientific Officer (CSO) of Luxa, delivered the opening keynote address at BIX 2026, presenting the latest frontiers in stem cell research and a vision for treating central nervous system disorders.

CSO Temple is credited with being the first in the world to identify neural stem cells. She is recognized as a world-renowned scholar who previously served as president of the International Society for Stem Cell Research (ISSCR). She leads the Neural Stem Cell Institute (NSCI), the first independent stem cell research institute in the United States, and established Luxa, a joint venture, in partnership with Y2 Solution in 2019.

RPESC-RPE-4W, currently under development by Luxa, is based on retinal pigment epithelium stem cells (RPESCs) isolated from adult eyes and operates on a mechanism of replacing damaged cells. In recognition of this innovation, the therapy received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and secured $4 million (approximately 5.4 billion won) in research funding from the California Institute for Regenerative Medicine (CIRM).

A market

validated by Biogen’s 8 trillion won deal… Luxa’s valuation ‘over 1 trillion won’

Analysts in the pharmaceutical and biotech industry predict that Luxa’s valuation will skyrocket following the release of these 24-month data. Recently, in the market for geographic atrophy (GA)—a type of dry age-related macular degeneration—mergers and acquisitions (M&A) worth trillions of won have been completed, proving the value of treatments.

Global biotech company Biogen acquired Apellis Pharmaceuticals for a total of approximately $5.6 billion (about 7.5 trillion won). This reflects the high regard for the success achieved by Apellis’ blockbuster new drug, “Cyphobre.” However, Cyphobre is merely a disease-modifying drug that slows the progression of the disease by inhibiting the complement system. In contrast, Luxa’s new drug is the only alternative that fundamentally restores vision by repairing damaged tissue. It is, in effect, a game-changer that shifts the paradigm of GA treatment—which had been limited to slowing the disease’s progression—toward “complete vision restoration.”

An investment industry insider predicted, “Considering the reality that companies with drugs that are merely disease-delaying agents are being acquired for trillions of won, Luxa’s value—having demonstrated vision regeneration effects over two years—far exceeds the $700 million (approximately 940.4 billion won) estimated by overseas institutions,” adding, “If a competition for technology acquisition among Big Pharma companies ensues, a valuation of over 1 trillion won would be a reasonable expectation.”

As the likelihood of Luxa’s clinical success grows, the stock price momentum and revaluation of Y2 Solution—Luxa’s largest shareholder—are also expected to gain significant traction. Y2 Solution has successfully transformed its business model by establishing its biofuel business as a new cash cow alongside its existing power supply unit (PSU) business. In the first half of this year alone, the company achieved cumulative sales of 174 billion won, surpassing last year’s annual sales in just one half-year. The abundant liquidity secured by maintaining operating profits for two consecutive quarters serves as a solid financial foundation to support Luxa’s new drug development.

Unlike typical biotech ventures that struggled with cash flow and were forced to sell promising technologies at bargain prices, Y2 Solution has gained formidable bargaining power thanks to its self-sustaining revenue structure. This allows the company to avoid being at the mercy of others in technology export negotiations and even consider independent development.

A Y2 Solution official emphasized, “Through this Phase 1/2a clinical trial, we have established long-term safety and efficacy,” adding, “We will finalize the commercial production process using cryopreserved cells to achieve tangible results in global technology exports.”